Improving Lifestyle Behavior by "Joven, Fuerte y Saludable" Multidisciplinary Program.

Breast Neoplasm Clinical Trial

Official title:

Efecto de Una intervención Multidisciplinaria de Estilo de Vida Sobre el Exposoma de Pacientes premenopáusicas Con cáncer de Mama Estadios I-III.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06090747
• Other study ID #: 023-005-OMI(CEI-05022)
• Status: Recruiting
• Phase: N/A
• Start date: March 9, 2023
• Est. completion date: December 31, 2028

Study information

• Verified date: October 2023
• Source: Instituto Nacional de Cancerologia de Mexico
• Contact: Marlid Cruz Ramos, PhD
• Phone: +525556280400
• Email: marlid.cruz[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Breast cancer is the leading cause of mortality in women worldwide. Latin-American women are diagnosed at younger ages, in advanced stages, and with aggressive molecular subtypes. Lifestyle seems related to these aggressive conditions and worse outcomes. The present study seeks to evaluate the effect of a hybrid multidisciplinary intervention for implementing a healthy lifestyle to modify the personal and internal exposome of young women with breast cancer. This randomized controlled experimental study with two groups:

Group 1: Hybrid multidisciplinary lifestyle education intervention. Group 2: Individualized hybrid multidisciplinary lifestyle interventions. The multidisciplinary lifestyle intervention program includes oncology, nutrition, physiotherapy, and psychology interventions.

Description:

Breast cancer (BC) is a leading cause of death in women worldwide, especially in Latin America, where patients often present with advanced stages of aggressive subtypes of BC at a younger age. The risk of BC depends on various factors, including hormone replacement therapy history, reproductive history, alcohol or tobacco consumption, physical activity, and dietary habits, collectively called exposome. Exposome refers to the exposure to environmental influences and biological responses throughout a person's life from the prenatal stage. It can be influenced by the environment, diet, behavior, and endogenous processes.

External exposome refers to environmental factors such as mental stress, climate, and lifestyle. In contrast, internal exposome are changes within an organism, such as increased stress hormones, inflammatory cytokines, and oxidative stress. Constant exposure to environmental factors, such as an unhealthy lifestyle, can cause cellular damage and contribute to the growth and evolution of tumors. Once cellular damage occurs, internal exposome promotes changes that create a harmful environment, favoring cancer cells to acquire coping mechanisms for stress and drugs, leading to resistance to oncological treatments.

Obesity is part of the personal exposome and can impact the internal exposome, potentially affecting BC patients. A significant percentage of patients diagnosed with BC (70.9%) are overweight or obese at the time of diagnosis. This weight gain usually occurs during systemic treatment, with 25% of patients gaining weight within six months, 32% between 6-12 months, and 20% between 12-18 months after diagnosis. Young women with breast cancer (YWBC) also experience an increase in weight since the initiation of oncological treatment and up to the second year of diagnosis (from 39% at baseline to 46% in two years), highlighting the importance of evaluating the implications of weight gain and whether early intervention would help control the risk factors mentioned earlier. Obesity may also be associated with worse disease-free and overall survival.

Weight gain in patients with BC is often associated with several factors, including systemic treatment, diagnosis at a young age, and lifestyle changes resulting from the disease or treatment. However, reduced physical activity is the primary mechanism underlying weight gain. The combination of chemotherapy and endocrine therapy is linked to higher weight gain, especially in patients who are premenopausal (an increase of up to 24 kg). In contrast, postmenopausal women tend to lose weight.

BC patients have reported experiencing physical symptoms and psychological distress, which can negatively impact their quality of life (QoL). These symptoms can affect their physical functioning, psychological well-being, and social support levels. YWBC is a vulnerable population with specific concerns such as fertility, self-image, QoL, sexuality, and personal goals and experience high anxiety and depression. Maintaining a healthy lifestyle can improve QoL and lead to better prognoses and lower mortality rates. For example, exercise can reduce breast cancer-related death risk by 30% and all-cause death risk by 41%. Patients undergoing oncology treatment face various nutritional challenges that differ based on the type and stage of cancer, and the treatments may worsen these challenges. Early nutritional screening and interventions are crucial in the cancer population, as emphasized in the clinical guidelines (ASPEN/ESPEN).

The Instituto Nacional de Cancerología (INCAN) in Mexico City offers a program called "Joven & Fuerte" for young women diagnosed with BC. However, the attention was not systematic, and it was difficult to measure the benefits of the intervention. So, the present study proposes a psychological intervention, side effect management, physical activity, sleep hygiene, and psychological strategies, with onsite and remote interventions to improve patient adherence and ensure timely attention. The study aims to evaluate the impact of early intervention on metabolic control in newly diagnosed BC patients, their QoL, and clinical outcomes.

METHODS A controlled trial design was adopted in which patients were assigned to two intervention groups according to the nutritional, psychological, or rehabilitation risk at baseline or according to their geographical localization. The first group will receive a hybrid multidisciplinary lifestyle education intervention, whereas the second group will receive an individualized hybrid multidisciplinary lifestyle intervention.

Patients will be recruited through an active program at the INCAN, where potential candidates will be identified and invited by the navigator at the program "Joven & Fuerte." After they sign the informed consent form (ICF), patients will be assigned into one of the two groups:

Group 1: Hybrid multidisciplinary lifestyle education intervention. Group 2: Individualized hybrid multidisciplinary lifestyle interventions. The initial proposal was a randomized assignment to each group; however, the pilot study revealed challenges for patients who lived far from the hospital, in other states or had personal obligations such as family or work. Therefore, the randomization process was adapted to meet the patient's needs. The intervention aims to facilitate patients' adherence and follow-up with healthcare providers. Additionally, patient preferences were considered when assigning them to a group.

Objectives.

To assess the ability of a personalized lifestyle intervention to support breast cancer patients undergoing active treatment to maintain or obtain a healthy lifestyle.

To evaluate adopting a healthy lifestyle, validated questionnaires will be applied to assess lifestyle components such as level of physical activity, sleep hygiene, and emotional distress (baseline, during, and after treatment).

To evaluate changes in internal exposome parameters such as body composition, biochemical, inflammatory, and metabolomic indicators will be measured.

To evaluate the effectiveness of a virtual educational program to support breast cancer patients in active treatment to maintain or obtain a healthy personal exposome and its usefulness in patients who live in remote locations or cannot attend a face-to-face consultation.

To evaluate the motivational and educational effect of a personalized follow-up by phone, Zoom, WhatsApp, or social networks.

To evaluate the implementation's effect on participants' quality of life. To evaluate the barriers and challenges to implementing the healthy life intervention.

The proposed indicators will make it possible to measure the effect of the proposed intervention on the exposome of the patients, as well as adherence to the intervention, through attendance at consultations and changes in lifestyle using validated questionnaires. Among the interventions, an individualized hybrid format is proposed, both with face-to-face consultations, as well as remote follow-up through telephone calls, video calls, or material sent through digital platforms, which will benefit patients who are far from the institute or who they have difficulties to attend due to travel times, work schedules; which translates into greater adherence to the intervention and positive changes in the lifestyle of patients. Finally, it is proposed to produce an educational manual and other printed or video support materials for patients, allowing the program to be replicated in other centers with similar needs in Mexico and Latin America. Additionally, the present study intends to use the variables obtained: the clinical, anthropometric, biochemical, inflammatory profile, and metabolites identified as possible biomarkers to develop a predictor algorithm for the deterioration of quality of life in patients.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 146
• Est. completion date: December 31, 2028
• Est. primary completion date: December 31, 2026
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

Inclusion Criteria:

• Women diagnosed with stage I-III BC, confirmed by pathology and image at the INCAN

• Candidates for multidisciplinary treatment including surgery, chemotherapy, and/or hormonal treatments.

• Signed the informed consent form

• Have access to a mobile phone or any electronic device with an active internet connection to receive the program information.

Exclusion Criteria:

• Patients with inflammatory cancer

• Those with cardiomyopathy or ventricular dysfunction (NYHA >II), arrythmia secondary to left ventricular ejection alterations that requires medication, previous myocardial infarction, or angina pectoris in the last six months

• Receiving treatment for cardiovascular or cerebrovascular disease, inflammatory bowel disease, malabsorption syndrome, rheumatoid arthritis, lupus, thyroid diseases, or Cushing syndrome

• Unable to walk for at least 1 km

• Have cardiovascular, respiratory, or musculoskeletal diseases that impede physical activity

• Pregnant or breastfeeding

• Have psychiatric conditions impeding active participation in this protocol

• Do not understand Spanish

Related Conditions & MeSH terms

• Breast Neoplasm
• Breast Neoplasms

Intervention

Behavioral:
• Hybrid lifestyle educational multidisciplinary intervention.
Participants will receive a standardized educational healthy lifestyle intervention. The information will be shared via digital tools such as mail, WhatsApp, zoom workshops, educational videos, "Joven, Fuerte y Saludable" webpage, "Joven, Fuerte y Saludable" mobile app, and face-to-face educational sessions.
• Hybrid lifestyle personalized multidisciplinary intervention.
Participants will receive a standardized educational healthy lifestyle intervention and personalized lifestyle intervention based on their clinical evaluation. Based on clinical records participants will be sent to nutritional, psychological, rehabilitation, and Mindfulness intervention. Educational and motivational strategies include digital tools such as mail, WhatsApp, zoom workshops, educational videos, the "Joven, Fuerte y Saludable" webpage, and the "Joven, Fuerte y Saludable" mobile app. And individualized follow-up through Mobile apps such as AVENA

Locations

Country	Name	City	State
Mexico	Dr. Marlid Cruz Ramos	México

Sponsors (6)

Lead Sponsor	Collaborator
Instituto Nacional de Cancerologia de Mexico	Anahuac University, Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz, Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran, Instituto Nacional de Rehabilitacion, Tecnologico de Monterrey

Country where clinical trial is conducted

Mexico, 

References & Publications (40)

Amadou A, Torres-Mejia G, Hainaut P, Romieu I. Breast cancer in Latin America: global burden, patterns, and risk factors. Salud Publica Mex. 2014 Sep-Oct;56(5):547-54. doi: 10.21149/spm.v56i5.7379. — View Citation

Barquera S, Hernandez-Barrera L, Trejo-Valdivia B, Shamah T, Campos-Nonato I, Rivera-Dommarco J. [Obesity in Mexico, prevalence andtrends in adults. Ensanut 2018-19.]. Salud Publica Mex. 2020 Nov-Dec;62(6):682-692. doi: 10.21149/11630. Spanish. — View Citation

Bessonneau V, Rudel RA. Mapping the Human Exposome to Uncover the Causes of Breast Cancer. Int J Environ Res Public Health. 2019 Dec 27;17(1):189. doi: 10.3390/ijerph17010189. — View Citation

Bose S, Allen AE, Locasale JW. The Molecular Link from Diet to Cancer Cell Metabolism. Mol Cell. 2020 Jun 18;78(6):1034-1044. doi: 10.1016/j.molcel.2020.05.018. Epub 2020 Jun 5. Erratum In: Mol Cell. 2020 Nov 5;80(3):554. — View Citation

Bustamante-Marin XM, Merlino JL, Devericks E, Carson MS, Hursting SD, Stewart DA. Mechanistic Targets and Nutritionally Relevant Intervention Strategies to Break Obesity-Breast Cancer Links. Front Endocrinol (Lausanne). 2021 Mar 17;12:632284. doi: 10.3389/fendo.2021.632284. eCollection 2021. — View Citation

Campbell-Enns H, Woodgate R. The psychosocial experiences of women with breast cancer across the lifespan: a systematic review protocol. JBI Database System Rev Implement Rep. 2015 Jan;13(1):112-21. doi: 10.11124/jbisrir-2015-1795. — View Citation

Cnop M, Foufelle F, Velloso LA. Endoplasmic reticulum stress, obesity and diabetes. Trends Mol Med. 2012 Jan;18(1):59-68. doi: 10.1016/j.molmed.2011.07.010. Epub 2011 Aug 31. — View Citation

Daiber A, Kroller-Schon S, Frenis K, Oelze M, Kalinovic S, Vujacic-Mirski K, Kuntic M, Bayo Jimenez MT, Helmstadter J, Steven S, Korac B, Munzel T. Environmental noise induces the release of stress hormones and inflammatory signaling molecules leading to oxidative stress and vascular dysfunction-Signatures of the internal exposome. Biofactors. 2019 Jul;45(4):495-506. doi: 10.1002/biof.1506. Epub 2019 Apr 2. — View Citation

De Cicco P, Catani MV, Gasperi V, Sibilano M, Quaglietta M, Savini I. Nutrition and Breast Cancer: A Literature Review on Prevention, Treatment and Recurrence. Nutrients. 2019 Jul 3;11(7):1514. doi: 10.3390/nu11071514. — View Citation

Demark-Wahnefried W, Hars V, Conaway MR, Havlin K, Rimer BK, McElveen G, Winer EP. Reduced rates of metabolism and decreased physical activity in breast cancer patients receiving adjuvant chemotherapy. Am J Clin Nutr. 1997 May;65(5):1495-501. doi: 10.1093/ajcn/65.5.1495. — View Citation

Di Meglio A, Martin E, Crane TE, Charles C, Barbier A, Raynard B, Mangin A, Tredan O, Bouleuc C, Cottu PH, Vanlemmens L, Segura-Djezzar C, Lesur A, Pistilli B, Joly F, Ginsbourger T, Coquet B, Pauporte I, Jacob G, Sirven A, Bonastre J, Ligibel JA, Michiels S, Vaz-Luis I. A phase III randomized trial of weight loss to reduce cancer-related fatigue among overweight and obese breast cancer patients: MEDEA Study design. Trials. 2022 Mar 4;23(1):193. doi: 10.1186/s13063-022-06090-6. — View Citation

Dieli-Conwright CM, Wong L, Waliany S, Bernstein L, Salehian B, Mortimer JE. An observational study to examine changes in metabolic syndrome components in patients with breast cancer receiving neoadjuvant or adjuvant chemotherapy. Cancer. 2016 Sep 1;122(17):2646-53. doi: 10.1002/cncr.30104. Epub 2016 May 24. — View Citation

Ee C, Cave A, Vaddiparthi V, Naidoo D, Boyages J. Factors associated with weight gain after breast cancer: Results from a community-based survey of Australian women. Breast. 2023 Jun;69:491-498. doi: 10.1016/j.breast.2023.01.012. Epub 2023 Jan 25. — View Citation

Fang M, Hu L, Chen D, Guo Y, Liu J, Lan C, Gong J, Wang B. Exposome in human health: Utopia or wonderland? Innovation (Camb). 2021 Oct 6;2(4):100172. doi: 10.1016/j.xinn.2021.100172. eCollection 2021 Nov 28. — View Citation

Febvey-Combes O, Jobard E, Rossary A, Pialoux V, Foucaut AM, Morelle M, Delrieu L, Martin A, Caldefie-Chezet F, Touillaud M, Berthouze SE, Boumaza H, Elena-Herrmann B, Bachmann P, Tredan O, Vasson MP, Fervers B. Effects of an Exercise and Nutritional Intervention on Circulating Biomarkers and Metabolomic Profiling During Adjuvant Treatment for Localized Breast Cancer: Results From the PASAPAS Feasibility Randomized Controlled Trial. Integr Cancer Ther. 2021 Jan-Dec;20:1534735420977666. doi: 10.1177/1534735420977666. — View Citation

Fowler S. Diabetes Prevention Program (V8) . NIDDK Central Repository. 2023; Resources for Research (R4R), https://repository.niddk.nih.gov/.

Gálvez-Hernández CL, Ortega Mondragón A, Villarreal-Garza C, Ramos Del Río B. Young women with breast cancer: Supportive care needs and resilience. Psicooncologia (Pozuelo de Alarcon). 2018;15(2):287-300.

Guarino A, Polini C, Forte G, Favieri F, Boncompagni I, Casagrande M. The Effectiveness of Psychological Treatments in Women with Breast Cancer: A Systematic Review and Meta-Analysis. J Clin Med. 2020 Jan 12;9(1):209. doi: 10.3390/jcm9010209. — View Citation

Hauner D, Rack B, Friedl T, Hepp P, Janni W, Hauner H. Rationale and description of a lifestyle intervention programme to achieve moderate weight loss in women with non-metastatic breast cancer: the lifestyle intervention part of the SUCCESS C Study. BMJ Nutr Prev Health. 2020 Sep 21;3(2):213-219. doi: 10.1136/bmjnph-2020-000119. eCollection 2020 Dec. — View Citation

Hoy MK, Winters BL, Chlebowski RT, Papoutsakis C, Shapiro A, Lubin MP, Thomson CA, Grosvenor MB, Copeland T, Falk E, Day K, Blackburn GL. Implementing a low-fat eating plan in the Women's Intervention Nutrition Study. J Am Diet Assoc. 2009 Apr;109(4):688-96. doi: 10.1016/j.jada.2008.12.016. — View Citation

KABAT-ZINN, Jon. Mindfulness-based interventions in context: past, present, and future. 2003.

Kalita-de Croft P, Sharma S, Sobrevia L, Salomon C. Extracellular vesicle interactions with the external and internal exposome in mediating carcinogenesis. Mol Aspects Med. 2022 Oct;87:101039. doi: 10.1016/j.mam.2021.101039. Epub 2021 Oct 8. — View Citation

Lengacher CA, Reich RR, Paterson CL, Shelton M, Shivers S, Ramesar S, Pleasant ML, Budhrani-Shani P, Groer M, Post-White J, Johnson-Mallard V, Kane B, Cousin L, Moscoso MS, Romershausen TA, Park JY. A Large Randomized Trial: Effects of Mindfulness-Based Stress Reduction (MBSR) for Breast Cancer (BC) Survivors on Salivary Cortisol and IL-6. Biol Res Nurs. 2019 Jan;21(1):39-49. doi: 10.1177/1099800418789777. Epub 2018 Aug 5. — View Citation

Li YR, Ro V, Tchou JC. Obesity, Metabolic Syndrome, and Breast Cancer: From Prevention to Intervention. Curr Surg Rep. 2018 Mar;6(3):7. doi: 10.1007/s40137-018-0204-y. Epub 2018 Feb 24. — View Citation

Makari-Judson G, Braun B, Jerry DJ, Mertens WC. Weight gain following breast cancer diagnosis: Implication and proposed mechanisms. World J Clin Oncol. 2014 Aug 10;5(3):272-82. doi: 10.5306/wjco.v5.i3.272. — View Citation

Montagnese C, Porciello G, Vitale S, Palumbo E, Crispo A, Grimaldi M, Calabrese I, Pica R, Prete M, Falzone L, Libra M, Cubisino S, Poletto L, Martinuzzo V, Coluccia S, Esindi N, Nocerino F, Minopoli A, Grilli B, Fiorillo PC, Cuomo M, Cavalcanti E, Thomas G, Cianniello D, Pinto M, De Laurentiis M, Pacilio C, Rinaldo M, D'Aiuto M, Serraino D, Massarut S, Caggiari L, Evangelista C, Steffan A, Catalano F, Banna GL, Scandurra G, Ferrau F, Rossello R, Antonelli G, Guerra G, Farina A, Messina F, Riccardi G, Gatti D, Jenkins DJA, Celentano E, Botti G, Augustin LSA. Quality of Life in Women Diagnosed with Breast Cancer after a 12-Month Treatment of Lifestyle Modifications. Nutrients. 2020 Dec 31;13(1):136. doi: 10.3390/nu13010136. — View Citation

Nyrop KA, Deal AM, Shachar SS, Park J, Choi SK, Lee JT, O'Hare EA, Wheless A, Carey LA, Muss HB. Weight trajectories in women receiving systemic adjuvant therapy for breast cancer. Breast Cancer Res Treat. 2020 Feb;179(3):709-720. doi: 10.1007/s10549-019-05501-8. Epub 2019 Nov 16. — View Citation

Perry S, Kowalski TL, Chang CH. Quality of life assessment in women with breast cancer: benefits, acceptability and utilization. Health Qual Life Outcomes. 2007 May 2;5:24. doi: 10.1186/1477-7525-5-24. — View Citation

Reynoso-Noveron N, Villarreal-Garza C, Soto-Perez-de-Celis E, Arce-Salinas C, Matus-Santos J, Ramirez-Ugalde MT, Alvarado-Miranda A, Cabrera-Galeana P, Meneses-Garcia A, Lara-Medina F, Bargallo-Rocha E, Mohar A. Clinical and Epidemiological Profile of Breast Cancer in Mexico: Results of the Seguro Popular. J Glob Oncol. 2017 Dec;3(6):757-764. doi: 10.1200/JGO.2016.007377. Epub 2017 Feb 8. — View Citation

Richards J, Arensberg MB, Thomas S, Kerr KW, Hegazi R, Bastasch M. Impact of Early Incorporation of Nutrition Interventions as a Component of Cancer Therapy in Adults: A Review. Nutrients. 2020 Nov 5;12(11):3403. doi: 10.3390/nu12113403. — View Citation

Rogers LQ, Courneya KS, Oster RA, Anton PM, Robbs RS, Forero A, McAuley E. Physical Activity and Sleep Quality in Breast Cancer Survivors: A Randomized Trial. Med Sci Sports Exerc. 2017 Oct;49(10):2009-2015. doi: 10.1249/MSS.0000000000001327. — View Citation

Ruiz-Vozmediano J, Lohnchen S, Jurado L, Recio R, Rodriguez-Carrillo A, Lopez M, Mustieles V, Exposito M, Arroyo-Morales M, Fernandez MF. Influence of a Multidisciplinary Program of Diet, Exercise, and Mindfulness on the Quality of Life of Stage IIA-IIB Breast Cancer Survivors. Integr Cancer Ther. 2020 Jan-Dec;19:1534735420924757. doi: 10.1177/1534735420924757. — View Citation

Shaikh H, Bradhurst P, Ma LX, Tan SYC, Egger SJ, Vardy JL. Body weight management in overweight and obese breast cancer survivors. Cochrane Database Syst Rev. 2020 Dec 11;12(12):CD012110. doi: 10.1002/14651858.CD012110.pub2. — View Citation

Snetselaar LG, de Jesus JM, DeSilva DM, Stoody EE. Dietary Guidelines for Americans, 2020-2025: Understanding the Scientific Process, Guidelines, and Key Recommendations. Nutr Today. 2021 Nov-Dec;56(6):287-295. doi: 10.1097/NT.0000000000000512. Epub 2021 Nov 12. — View Citation

Urech C, Grossert A, Alder J, Scherer S, Handschin B, Kasenda B, Borislavova B, Degen S, Erb J, Faessler A, Gattlen L, Schibli S, Werndli C, Gaab J, Berger T, Zumbrunn T, Hess V. Web-Based Stress Management for Newly Diagnosed Patients With Cancer (STREAM): A Randomized, Wait-List Controlled Intervention Study. J Clin Oncol. 2018 Mar 10;36(8):780-788. doi: 10.1200/JCO.2017.74.8491. Epub 2018 Jan 25. — View Citation

van den Berg SW, Gielissen MF, Custers JA, van der Graaf WT, Ottevanger PB, Prins JB. BREATH: Web-Based Self-Management for Psychological Adjustment After Primary Breast Cancer--Results of a Multicenter Randomized Controlled Trial. J Clin Oncol. 2015 Sep 1;33(25):2763-71. doi: 10.1200/JCO.2013.54.9386. Epub 2015 Jul 13. — View Citation

Villarreal-Garza C, Aguila C, Platas A, Lara-Guerra H. [Clinical Forum: Breast cancer in young women in Mexico: unmet needs and clinical challenges]. Rev Invest Clin. 2014 Nov-Dec;66(6):547-58. No abstract available. Spanish. — View Citation

Villarreal-Garza C, Platas A, Miaja M, Fonseca A, Mesa-Chavez F, Garcia-Garcia M, Chapman JA, Lopez-Martinez EA, Pineda C, Mohar A, Galvez-Hernandez CL, Castro-Sanchez A, Martinez-Cannon BA, Barragan-Carrillo R, Munoz-Lozano JF, Goss P, Bargallo-Rocha JE, Aguilar D, Cardona S, Canavati M. Young Women With Breast Cancer in Mexico: Results of the Pilot Phase of the Joven & Fuerte Prospective Cohort. JCO Glob Oncol. 2020 Mar;6:395-406. doi: 10.1200/JGO.19.00264. — View Citation

Villarreal-Garza C, Platas A, Miaja M, Mesa-Chavez F, Garcia-Garcia M, Fonseca A, Pineda C, de la Rosa-Pacheco S, Galvez-Hernandez CL, Bargallo-Rocha E, Castro J, Rodriguez-Gomez D, Cruz-Ramos M, Mohar A. Patients' satisfaction with a supportive care program for young breast cancer patients in Mexico: Joven & Fuerte supports patients' needs and eases their illness process. Support Care Cancer. 2020 Oct;28(10):4943-4951. doi: 10.1007/s00520-020-05334-y. Epub 2020 Feb 4. — View Citation

Widiasih R, Ermiati, Jayanti TN, Rais Y. Psychosocial Interventions for Improving the Quality of Life in Breast Cancer Survivors: A Literature Review. In: IOP Conference Series: Earth and Environmental Science. Institute of Physics Publishing; 2019.

* Note: There are 40 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adoption of healthy lifestyle	The patient lifestyle compliance measured by the scores of World Cancer Research Fund (WCRF) / American Institute for Cancer Research (AICR) questionnaire, SCORE = 5	Baseline evaluation and final evaluation (18 months).
Primary	Changes on 24-hour reminder	Evaluate the changes on daily nutritional intake (total energy, carbohydrate, protein and, lipids grams)	Baseline, 3, 6, 12 and 18 months.
Primary	Education and Motivational effectiveness of digital tools.	To evaluate the motivational and educational effect of a personalized follow-up by phone, Zoom, WhatsApp, or social networks (number of views in videos, number of Zoom sessions, number o WA calls).	3, 6, 12 and 18 months.
Primary	Physical Activity changes	Evaluate the changes on physical activitiy by International Physical Activity Questionnaire (IPAQ) score (high: 1500 to 3000 METS per/week; moderate: 600 MET per/week.	Baseline, 3, 6,12 and 18 months.
Primary	Quality of sleep changes	Evaluate the quality of sleep changes by Pittsburgh Sleep Quality Index (PSQI). Total Score 0 to 21. Score 0 (No sleep difficulty); Score 1 to7 (mild sleep difficulty); Score 8-14 (moderate sleep dificulty); 15-21 (severe sleep difficulty).	Baseline, 3, 6,12 and 18 months.
Primary	Depression risk evaluation	Patient Health Questionnaire (PHQ-9) 1-4 Minimal depression 5-9 Mild depression 10-14 Moderate depression 15-19 Moderately severe depression 20-27 Severe depression	Baseline, 3, 6,12 and 18 months.
Primary	Anxiety risk evaluation	Generalized Anxiety Disorder Assessment (GAD-7) 0-4: minimal anxiety 5-9: mild anxiety 10-14: moderate anxiety 15-21: severe anxiety	Baseline, 3, 6,12 and 18 months.
Primary	Minfulness evaluation - How having a concentrated mind affects on daily life	Five Facet Mindfulness Questionnaire (FFMQ) 1-2: Lack of concentrated mind 3: Intermediate attention awareness 4-5: Advance attention awareness	Baseline, 3, 6,12 and 18 months.
Primary	Body composition - Body fat	To evaluate the Effect of lifestyle intervention on: Body fat percentage (acceptable fat percentage <31%)	Baseline, 3, 6,12 and 18 months.
Primary	Biochemical parameters - Inflammatory cytokines	To evaluate the effect of lifestyle intervention on biochemical parameters: Cytokines level	Baseline, 3, 6,12 and 18 months.
Primary	Anthropometric measurements - Body weight	Changes in: Body weight (kg)	Baseline, 3, 6,12 and 18 months.
Primary	Minfulness evaluation - Disposition to attention awareness	Mindful Attention Awareness Scale (MAAS) 1-2: Lack of attention awareness 3: Intermediate attention awareness 4-5: Advance attention awareness 6: Overvalued (questionnaire was notanswered honestly)	Baseline, 3, 6,12 and 18 months.
Primary	Minfulness evaluation - Disposition to mindfulness	Cognitive and Affective Mindfulness Scale-Revised (CAMS-R) 1-2: Lack of disposition 3: Intermediate disposition 4: Advance into mindfulness	Baseline, 3, 6,12 and 18 months.
Primary	Body composition - Muscle	To evaluate the Effect of lifestyle intervention on: Muscle (muscle mass in kg and muscle mass index =6.42 kg/m2)	Baseline, 3, 6,12 and 18 months.
Primary	Biochemical parameters - Glucose	To evaluate the effect of lifestyle intervention on biochemical parameters: Blood glucose <135mg/dL	Baseline, 3, 6,12 and 18 months.
Primary	Biochemical parameters - Lipid profile	To evaluate the effect of lifestyle intervention on biochemical parameters: LDL<100mg/dL, HDL >40mg/dL and triglycerides <150mg/dL)	Baseline, 3, 6,12 and 18 months.
Primary	Anthropometric measurements - Waist circumference	Changes in: Waist circumference (cm)	Baseline, 3, 6,12 and 18 months.
Primary	Anthropometric measurements - Waist to hip ratio	Changes in: Waist to hip ratio (<0.8)	Baseline, 3, 6,12 and 18 months.
Secondary	Improvement of quality of life parameters with lifestyle intervention- QLQ-C30	Effect of lifestyle intervention on quality of life measured by European Organization of Research and Treatment of Cancer Quality of Life Questionnarie (QLQ-C30)	Baseline, 3, 6 ,12 and 18 months.
Secondary	Barriers and challenges to implement the lifestyle intervention - CFIR	To identify the barriers and challenges for the implementation of the healthy lifestyle intervention.; CFIR (Consolidated Framework for Implementation Research) - qualitative evaluation	3, 6, 12 and 18 months.
Secondary	Barriers and challenges to implement the lifestyle intervention - RE-AIM	To identify the barriers and challenges for the implementation of the healthy lifestyle intervention.; RE-AIM (Reach, Effectiveness, Adoption, Implementation, Maintenance)	3, 6, 12 and 18 months.
Secondary	Improvement of quality of life parameters with lifestyle intervention- QLQ-BR23	Effect of lifestyle intervention on quality of life measured by Quality of Life Questionnarie Breast Cancer (QLQ-BR23) - Sympton scale score.	Baseline, 3, 6 ,12 and 18 months.